NCT01082601撤回不适用
Pulmonary Vein Isolation for Rhythm Control in Patients With Atrial Fibrillation and Left Ventricular Dysfunction: A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Improvement in LVESV by 15% or more from baseline at 6 months
研究概览
简要总结
To compare heart function, symptoms, exercise capacity and quality of life in patients with Congestive Heart Failure (CHF) and Atrial Fibrillation (AF)before and after catheter ablation.
Hypothesis: Restoration and maintenance of sinus rhythm by catheter ablation, without the use of antiarrhythmic drugs, in AF and CHF improves heart failure status.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years to 80 years
- •Clinical diagnosis of CHF based on symptoms (Shortness of breath, fatigue, peripheral edema)
- •Systolic left ventricular dysfunction with ejection fraction 40% or less
- •NYHA Class I, II or III heart failure
- •Paroxysmal AF(2 or more episodes in one month) that terminate within 7 days:or persistent AF (more than 7 days or less than 7 days but terminated with pharmacologic or electrical cardioversion).
- •Willing and able to sign informed consent
排除标准
- •Previous ablation
- •Left atrial size greater than 60mm(parasternal view on transthoracic echocardiogram)
- •AF episodes triggered by another uniform arrhythmia(e.g.atrial flutter or atrial tachycardia)
- •Active alcohol or drug abuse, which may be causative of AF
- •Severe valvular disease requiring surgical repair
- •Myocardial infarction within 6 months of enrollment
- •Abnormality that prevents catheter introduction
- •Coronary surgical revascularization or other cardiac surgery within 6 months of enrollment
- •Patients in whom heart transplant expected with 6 months
- •AF deemed secondary to a transient or correctable cause (e.g.electrolyte imbalance ,trauma,recent surgery,,infection, toxic ingestion or endocrinopathy
- •Pregnancy or women of child bearing potential & not on reliable method of birth control
- •Contraindication to Warfarin therapy or other bleeding diathesis
- •Participation in another clinical trial
- •Inaccessable to follow-up
- •Life expectancy of less than 24 months caused by reasons other than heart disease
- •Renal failure requiring dialysis
- •Decompensated CHF within 48 Hours of enrollment
- •Second or third degree AV block or sinus pause greater than 3 seconds, resting heart rate less 30 bpm without a permanent pacemaker
- •A history of drug induced Torsades de Pointes or congenital long QT syndrome
- •Currently responding to antiarrhythmic drug therapy
- •Uninterrupted AF for more than 12 months prior to randomization unless sinus rhythm maintained for 24 hours or longer.
- •Unwilling or unable to sign informed consent
结局指标
主要结局
Improvement in LVESV by 15% or more from baseline at 6 months
时间窗: 6 months
次要结局
- Remodeling as demonstrated by atrial & ventricular dimensions on echocardiogram(6 months)
- NYHA Class(6 months)
- Quality of Life(6 months)
- Six minute hall walk test(6 months)
- Hospitalization for HF(one year)
- Absence of Atrial fibrillation(one year)
研究者
研究点 (2)
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